510(k) K212790 ยท GEX Powered Laser Surgical Instrument
XLase Plus
| Applicant | Biotec Italia, Srl, Dueville (Vi), IT |
| Decision | Substantially Equivalent, Aug 15, 2022 |
| Received | Sep 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212790
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.